RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs, such as doxorubicin, near the tumor. Giving sunitinib together with chemoembolization may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.

Overall Survival [ Time Frame: Every 6 months after removal from treatment till death ] [ Designated as safety issue: No ]

median survival in months

Tissue Perfusion, Ktrans, IAUC, and Percent Viable Tumor as Measured by DCE-MRI at Baseline and on Days 8 (Before Transarterial Chemoembolization), 10, and 35 [ Time Frame: Baseline, day 8, day 10, day 28 and day 35 ] [ Designated as safety issue: No ]

oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses

Drug: doxorubicin hydrochloride

Transarterial chemoembolization

Drug: sunitinib malate

Given Orally

Other: laboratory biomarker analysis

Correlative Study

Procedure: hepatic artery embolization

Surgical procedure

Procedure: quality-of-life assessment

Correlative Study

Detailed Description:

OBJECTIVES:

Primary

To determine the progression-free survival at 4 months of patients treated with this regimen.

Secondary

To determine overall survival of these patients.

To determine if dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can be used to measure decrease in tumor perfusion and vascular permeability as a result of treatment with sunitinib malate in combination with TACE, and if it can be useful in prognosis.

To examine the safety and tolerability of this regimen.

To determine if a change in circulating endothelial precursor cell number and total monocyte count on days 3, 8, 10, and 35 of therapy (as compared with levels at baseline) and decrease in soluble vascular endothelial growth factor receptor-2 in serum on days 8 (before TACE), 10, and 35 of therapy (as compared with baseline) correlate with improved response and survival.

To determine the effect of this therapy on quality of life as measured by the FACT-HEP scale prior to each course of therapy.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses. Patients undergo hepatic artery chemoembolization with doxorubicin hydrochloride on day 8 of course 1 only. Treatment with sunitinib malate repeats every 6 weeks* in the absence of disease progression or unacceptable toxicity.

NOTE: *Course 1 is 7 weeks in duration; all subsequent courses are 6 weeks in duration.

Doses of ≤ 1 mg/day are allowed for prophylaxis of thrombosis as long as INR ≤ 1.5

Both full dose and prophylactic dose low molecular weight heparin allowed as long as PT INR ≤ 1.5

No anticipated major surgery during and for 3 months after completion of study treatment

No other concurrent investigational agents

No other concurrent anticancer therapy

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00524316